<p><strong><em>BGM0504 显示出总体良好的耐受性</em></strong></p>
<p><strong><em>总体安全性、药代动力学和疗效特征支持每日一次口服给药</em></strong></p>
<p>, /PRNewswire/ -- 博瑞医药（SSE: 688166，&#34;博瑞&#34;或&#34;公司&#34;）今天宣布了 BGM0504 的第一阶段临床研究的积极顶线结果，该药物是一种正在研究的口服 GLP-1/GIP 双受体激动剂，参与者为中国和美国的成年人，包括健康志愿者和超重或肥胖个体。</p>
<p>在这两项研究中，BGM0504 总体耐受性良好，没有严重不良事件。当观察到胃肠道不良事件时，主要为轻度至中度，且为短暂性，与该类药物的已知特征一致。基于意向治疗分析的初步疗效结果显示，体重有显著减少，在中国研究中，四周治疗后平均体重减少范围为 1.0% 至 5.6%，而在美国研究中，五至八周治疗后平均体重减少范围为 2.7% 至 8.2%。</p>
<p>中国第一阶段研究（CTR20253763 / NCT07239973）是一项随机、双盲、安慰剂对照试验，旨在评估 BGM0504 在健康参与者和非糖尿病超重或肥胖个体中的安全性、耐受性、药代动力学和初步疗效。共有 75 名参与者入组并完成了研究。BGM0504 每日一次给药，剂量范围为 10 mg 至 80 mg，持续四周。该化合物在所有剂量水平上总体耐受性良好，没有报告严重或意外的不良事件。胃肠道不良事件大多为轻度（1 级）且为短暂性。药代动力学分析显示，稳态暴露在给药约两至三周后达到，并且暴露量一般呈剂量比例增加。经过四周治疗，接受 BGM0504 的参与者相较基线显示出体重减少，平均减少范围为 1.0% 至 5.6%（最小二乘均值）在各剂量组中。</p>
<p>美国第一阶段研究（NCT07166081）是一项随机、安慰剂对照的多次递增剂量试验，评估 BGM0504 的安全性、耐受性和初步疗效。共有 80 名参与者入组，其中 64 名接受了 BGM0504，16 名接受了安慰剂。参与者每日一次给药，剂量范围为 20 mg 至 80 mg，治疗持续时间为五至八周，具体取决于剂量组，并且在目标剂量下至少给药四周。BGM0504 总体耐受性良好，没有报告严重不良事件。最常观察到的不良事件主要为胃肠道性质，通常为轻度至中度，且为短暂性。初步疗效分析显示体重减少的剂量反应，经过五至八周治疗后，平均体重减少范围为 2.7% 至 8.2%（最小二乘均值）。</p>
<p>这些研究的详细结果预计将在今年晚些时候的科学会议上公布。</p>
<p><strong>BGM0504 项目概述</strong></p>
<p>BGM0504 正在开发口服和皮下给药形式，作为公司在肥胖及相关代谢疾病领域更广泛战略的一部分。皮下给药形式已处于开发的高级阶段，中国第二阶段研究和美国桥接研究已完成，目前正在进行多项第三阶段研究。</p>
<p>本公告中披露的数据基于正在进行的临床研究的初步分析。随着额外数据的可用性和进一步分析的进行，结果和解释可能会发生变化。</p>
<p>BGM0504 仍然是一种研究药物，尚未在任何国家获得市场批准。药物开发涉及重大风险和不确定性，临床试验结果可能无法预测未来结果。需要进一步研究以确定 BGM0504 的安全性和有效性。</p>
<p>来源：博瑞医药</p>
<p><img src="https://imageproxy.pbkrs.com/https://rt.prnewswire.com/rt.gif/query-RGF0ZUlkPTIwMjYwMzI1Jk5ld3NJdGVtSWQ9Q04xODgzMyZUcmFuc21pc3Npb25fSWQ9MjAyNjAzMjUwMjMyUFJfTkVXU19VU1BSX19fX19DTjE4ODMz?x-oss-process=image/auto-orient,1/interlace,1/resize,w_1440,h_1440/quality,q_95/format,jpg" alt="" original-src="https://imageproxy.pbkrs.com/https://rt.prnewswire.com/rt.gif/query-RGF0ZUlkPTIwMjYwMzI1Jk5ld3NJdGVtSWQ9Q04xODgzMyZUcmFuc21pc3Npb25fSWQ9MjAyNjAzMjUwMjMyUFJfTkVXU19VU1BSX19fX19DTjE4ODMz"/></p>

博瑞医药

<p>博瑞医药（BrightGene Bio-Medical Technology Co., Ltd.）宣布了其口服 GLP-1/GIP 双受体激动剂 BGM0504 在中国和美国的第一阶段临床研究的积极顶线结果。该药物耐受性良好，没有严重不良事件。初步疗效结果显示，在中国治疗后体重减少了 1.0% 至 5.6%，在美国减少了 2.7% 至 8.2%。BGM0504 仍处于研究阶段，尚未获得上市批准。需要进一步研究以确认其安全性和有效性</p>

<p><strong><em>BGM0504 shown to be generally well tolerated</em></strong></p>
<div class="lb-trans"><p><strong><em>BGM0504 显示出总体良好的耐受性</em></strong></p>
</div><p><strong><em>Overall safety, pk, and efficacy profile supports once-daily oral dosing</em></strong></p>
<div class="lb-trans"><p><strong><em>总体安全性、药代动力学和疗效特征支持每日一次口服给药</em></strong></p>
</div><p>, /PRNewswire/ -- BrightGene Bio-Medical Technology Co., Ltd. (SSE: 688166, &#34;BrightGene&#34; or &#34;the Company&#34;) today announced positive topline results from Phase 1 clinical studies of BGM0504, an investigational oral GLP-1/GIP dual receptor agonist, in adult participants in China and the United States, including healthy volunteers and individuals with overweight or obesity.</p>
<div class="lb-trans"><p>, /PRNewswire/ -- 博瑞医药（SSE: 688166，&#34;博瑞&#34;或&#34;公司&#34;）今天宣布了 BGM0504 的第一阶段临床研究的积极顶线结果，该药物是一种正在研究的口服 GLP-1/GIP 双受体激动剂，参与者为中国和美国的成年人，包括健康志愿者和超重或肥胖个体。</p>
</div><p>Across both studies, BGM0504 was generally well tolerated, with no serious adverse events. Gastrointestinal adverse events, when observed, were predominantly mild to moderate in severity and transient, consistent with the known profile of this class. Preliminary efficacy results based on an intent-to-treat analysis showed meaningful reductions in body weight, with mean body weight reductions ranging from 1.0% to 5.6% after four weeks of treatment in the China study and from 2.7% to 8.2% after five to eight weeks of treatment in the U.S. study.</p>
<div class="lb-trans"><p>在这两项研究中，BGM0504 总体耐受性良好，没有严重不良事件。当观察到胃肠道不良事件时，主要为轻度至中度，且为短暂性，与该类药物的已知特征一致。基于意向治疗分析的初步疗效结果显示，体重有显著减少，在中国研究中，四周治疗后平均体重减少范围为 1.0% 至 5.6%，而在美国研究中，五至八周治疗后平均体重减少范围为 2.7% 至 8.2%。</p>
</div><p>The China Phase 1 study (CTR20253763 / NCT07239973) was a randomized, double-blind, placebo-controlled trial designed to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of BGM0504 in healthy participants and non-diabetic individuals with overweight or obesity. A total of 75 participants were enrolled and completed the study. BGM0504 was administered once daily at doses ranging from 10 mg to 80 mg for four weeks. The compound was generally well tolerated across all dose levels, with no serious or unexpected adverse events reported. Gastrointestinal adverse events were mostly mild (Grade 1) and transient. Pharmacokinetic analyses showed that steady-state exposure was achieved after approximately two to three weeks of dosing and that exposure increased in a generally dose-proportional manner. After four weeks of treatment, participants receiving BGM0504 demonstrated reductions in body weight relative to baseline, with mean reductions ranging from 1.0% to 5.6% (least squares mean) across dose groups.</p>
<div class="lb-trans"><p>中国第一阶段研究（CTR20253763 / NCT07239973）是一项随机、双盲、安慰剂对照试验，旨在评估 BGM0504 在健康参与者和非糖尿病超重或肥胖个体中的安全性、耐受性、药代动力学和初步疗效。共有 75 名参与者入组并完成了研究。BGM0504 每日一次给药，剂量范围为 10 mg 至 80 mg，持续四周。该化合物在所有剂量水平上总体耐受性良好，没有报告严重或意外的不良事件。胃肠道不良事件大多为轻度（1 级）且为短暂性。药代动力学分析显示，稳态暴露在给药约两至三周后达到，并且暴露量一般呈剂量比例增加。经过四周治疗，接受 BGM0504 的参与者相较基线显示出体重减少，平均减少范围为 1.0% 至 5.6%（最小二乘均值）在各剂量组中。</p>
</div><p>The U.S. Phase 1 study (NCT07166081) was a randomized, placebo-controlled, multiple ascending dose trial evaluating safety, tolerability and preliminary efficacy of BGM0504. A total of 80 participants were enrolled, including 64 who received BGM0504 and 16 who received placebo. Participants received once-daily dosing across dose levels ranging from 20 mg to 80 mg, with treatment durations of five to eight weeks depending on dose cohort and at least four weeks of dosing at the target dose. BGM0504 was generally well tolerated, with no serious adverse events reported. The most commonly observed adverse events were gastrointestinal in nature, were generally mild to moderate, and were transient. Preliminary efficacy analyses demonstrated does response in weight reduction, with mean body weight reductions ranging from 2.7% to 8.2% (least squares mean) after five to eight weeks of treatment.</p>
<div class="lb-trans"><p>美国第一阶段研究（NCT07166081）是一项随机、安慰剂对照的多次递增剂量试验，评估 BGM0504 的安全性、耐受性和初步疗效。共有 80 名参与者入组，其中 64 名接受了 BGM0504，16 名接受了安慰剂。参与者每日一次给药，剂量范围为 20 mg 至 80 mg，治疗持续时间为五至八周，具体取决于剂量组，并且在目标剂量下至少给药四周。BGM0504 总体耐受性良好，没有报告严重不良事件。最常观察到的不良事件主要为胃肠道性质，通常为轻度至中度，且为短暂性。初步疗效分析显示体重减少的剂量反应，经过五至八周治疗后，平均体重减少范围为 2.7% 至 8.2%（最小二乘均值）。</p>
</div><p>Detailed results from these studies are expected to be presented at a scientific conference later this year.</p>
<div class="lb-trans"><p>这些研究的详细结果预计将在今年晚些时候的科学会议上公布。</p>
</div><p><strong>BGM0504 Program Overview</strong></p>
<div class="lb-trans"><p><strong>BGM0504 项目概述</strong></p>
</div><p>BGM0504 is being developed in both oral and subcutaneous formulations as part of the Company's broader strategy in obesity and related metabolic diseases. The subcutaneous formulation is at an advanced stage of development, with China Phase 2 studies and a U.S. bridging study completed and multiple Phase 3 studies currently ongoing.</p>
<div class="lb-trans"><p>BGM0504 正在开发口服和皮下给药形式，作为公司在肥胖及相关代谢疾病领域更广泛战略的一部分。皮下给药形式已处于开发的高级阶段，中国第二阶段研究和美国桥接研究已完成，目前正在进行多项第三阶段研究。</p>
</div><p>The data disclosed in this announcement are based on preliminary analyses of ongoing clinical studies. As additional data become available and further analyses are conducted, the results and interpretations may be subject to change.</p>
<div class="lb-trans"><p>本公告中披露的数据基于正在进行的临床研究的初步分析。随着额外数据的可用性和进一步分析的进行，结果和解释可能会发生变化。</p>
</div><p>BGM0504 remains an investigational drug and has not been approved for marketing in any country. Drug development involves substantial risks and uncertainties, and clinical trial results may not be predictive of future outcomes. Further studies are required to establish the safety and efficacy of BGM0504.</p>
<div class="lb-trans"><p>BGM0504 仍然是一种研究药物，尚未在任何国家获得市场批准。药物开发涉及重大风险和不确定性，临床试验结果可能无法预测未来结果。需要进一步研究以确定 BGM0504 的安全性和有效性。</p>
</div><p>SOURCE BrightGene</p>
<div class="lb-trans"><p>来源：博瑞医药</p>
</div><p><img src="https://imageproxy.pbkrs.com/https://rt.prnewswire.com/rt.gif/query-RGF0ZUlkPTIwMjYwMzI1Jk5ld3NJdGVtSWQ9Q04xODgzMyZUcmFuc21pc3Npb25fSWQ9MjAyNjAzMjUwMjMyUFJfTkVXU19VU1BSX19fX19DTjE4ODMz" alt="" original-src="https://rt.prnewswire.com/rt.gif?NewsItemId=CN18833&amp;Transmission_Id=202603250232PR_NEWS_USPR_____CN18833&amp;DateId=20260325"/></p>

博瑞医药宣布其口服药物 BGM0504 在中国和美国的肥胖症 1 期试验中取得了积极的顶线结果